Resume

Resume Details
A. K.
Location	Delaware, OH
Contact	Click to View Contact
Source	Direct Candidate
Salary	N.A.
Rate	N.A.
Resume

SPECIALIZED IN
CSV, Enterprise Level Applications
TrackWise, LMS, LIMS and Quality CenterTest Management

SUMMARY

About 8+ years of experience in Validation with emphasis on Computer Systems Validation and with profound knowledge of current validation practices,  FDA 21 CFR Part 11, 58, 210, 211, 312, 820, GAMP 4 and 5 guidelines, cGXP (cGMP, cGCP, cGLP, GDP), QSR, ISO and SOX.
Good knowledge of Validation Life Cycle (VLC) and Software Development Life Cycle (SDLC) with Waterfall, Agile, Spiral, V-Model, SCRUM and Rational Unified Process Model (RUP).
Excellent experience in validating wide variety of applications and infrastructure - SAP R-3, Excel spreadsheets, EDMS: Documentum, EQMS:TrackWise, Learning Management System (LMS), and Laboratory Information Management System(LIMS).
Experienced in development of Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM) in validation deliverables.
Extensive experience with Learning Managing Systems (LMS), Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), Data Migration and Adverse Event Reporting System (AERS).
Very good knowledge of instruments used in the pharmaceutical industry - Spectrophotometers, Chromatographs, HPLC, Capillary Electrophoresis, GC, UV- Vis, PXRD, LC-MS, TOC, DSC and TGA.
Good experience in Requirement Traceability Matrix (RTM), and Validation summary report writing.
Good experience at System support and maintenance validation procedures such as Change control, Change Notification Form, and Incident and problem management like CAPA.
Experience in both AERS: Oracle*s ARGUS safety and ARIS G software tools.
Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations. 
Substantial experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS), Test plans, Test cases, test scripts, Test reports and Test requirements
Experience in GAP analysis and Preparing Remediation plans with the knowledge of Project Management.
Extensive experience in performing ERES Risk Assessment and other Risk Based methodology and risk management tools such as FMEA and PHA.
Proficient in performing integration testing, functionality testing,unit testing, Integration testing, System testing and User acceptance testing (UAT), D2D testing, E2E testing and black-box testing.
Strong hands on experience in using automated testing tools like Quick Test Professional (QTP), Win Runner and Load Runner.
Expertise in using SQL for data validation and manipulation and managing records.
Excellent adaptation quality to work in both individual and team work settings.
Good acquaintance and practicing of GxPi*s principles of Lean Compliance. Strong capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.


PROFESSIONAL SKILLS:
Computer systems validation21 CFR part11, 210,211,  GxP, SDLC, Validation Protocols (IQ, OQ, PQ), URS, FRS, QTP, validation master plan, Test scripts, SOP*s, RTM, AERS, TrackWise, LIMS, summary reports, executing test scripts for validation, LMS.
Test ToolsQuality Center. QTP, Load runner and Wind Runner.
Medical InstrumentationAgilent chemstation (HPLC-GC: LC-MS), Waters Empower (HPLC), UV-VIS, Rigaku-IV(PXRD), Incubators, Centrifuges, Sterlizers, and Autoclaves e.t.c.
Operating SystemsWindows XP-2000-ME-98,Mac, UNIX-Linux
ProgrammingC, C++, SQL, PL-SQL, HTML.
BrowsersInternet Explorer, Netscape Navigator, Firefox
Office toolsMS Word, MS Excel, MS PowerPoint, Chemdraw, JMP-SAS (statistical tool for DOE), SharePoint, Vision, Documentum.


PROFESSIONAL EXPERIENCE

CVS Caremark, OH
Feb 2013 - till date
Validation-Compliance Analyst

Responsibilities :
Responsible for documenting and reviewing Validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures  Records) and FDA Regulations.
Maintained requirements and supported the team lead with Software Development Life Cycle (SDLC) through AGILE-SCRUM Methodologies.
Created the Enhancement Assessment Matrix for the upgrade and categorized enhancements as Impact and No Impact items and Risk involved with implementing them.
Communicated and worked with PV group and developed suitable requirements as per URS specifications.
Coordinated the execution of Operational Qualifications Test Scripts for different modules and specifications involving configuration and migration from one environment to other using Configuration Migrator Utility.
Developed IQ and PQ Scripts for Track Wise and performed the dry run in Quality Center.
Created Validation Plan, Test Plans, Test cases, Test reports and Technical Architecture Specification Documents as per FDA and company SOP.
Validated LMS 6.4 to ensure 21CFRPart 11 and cGxP compliance.
Developed Working Instructions for different users of the application and assisted in drafting the Standard Operating Procedures (SOP).
Responsible to define test Requirements, run manual and automated tests, add and track defects using Mercury Quality Center.
Conducted Regression testing and running of the scripts in validated environment for Track Wise system implementation.
Designed the Training Plan for the End users and Local Administrators for Track Wise and managed (as a Test Coordinator) the testing efforts
Developed Detailed ERES, FMEA, and PHE risk assessment documentation for managing the risk levels used before validation the system.
Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases using QC.
Performed Gap Analysis and Remediation procedures for LIMS modules that helped in preventing bugs.
Reviewed and updated end to end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures.
Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
Created of new templates and forms to bring consistency in documentation and maintained the Discrepancy Log file.
PAREXEL, NC
Oct 2011 - Jan 2013
Computer Validation Engineer

Responsibilities :
Prepared documents for all aspects of the computer system validation life cycle and SDLC (Agile, Waterfall), in accordance with FDA design control and regulations, particularly 21 CFR Part 11.
Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
Managed and organized requirement coverage, Test Case Management and Defect Management by communicating between Team Lead, Developers to resolve the technical issues.
Prepared CAPA plan, test cases, test scripts, test summary reports for overall product, part wise assessment and improvement and reported concerns if any to the suppliers
Performed Computer System Validation Assessment for Track-wise system to identify the validation deliverables for the project implementation
Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
Created Requirement Traceability Matrix (RTM) which helped to see whether the user requirements were met with the business requirements.
Extensively used Enterprise Data Management platform Documentum for maintaining validation life cycle documents.
Developed test cases and wrote test scripts to perform system testing.
Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
Maintained reports for medical devices through DHF and DMR.
Prepared UAT test cases and mentored execution of UAT test cases to business users.
Reviewed and Positive testing, Negative testing, Regression testing for the Chemstation software using Quality Center tool along with Back-End integration testing to ensure data consistency on front-end.
Involved in up gradation of the software*s of the laboratory instrumentation and overcame the technical obstacles.
Organized, developed, and managed multiple projects with effective time management and conducted meetings to discuss compliances with the FDA rules and regulation.
 TEVA, AZ
Feb 2010 - Sep 2011
Validation Specialist

Responsibilities :
Responsible for developing Requirement Specification Document, System Requirement Specification, and Design Specification.
Gathered business requirements in compliance with 21 CFR part 11.
Involved in creation of Master Test Plan to strategize the test approach in various test cycles.
Created Qualification Protocols to strategize the test approach in Validation and Production environments.
Developed IQ-OQ-PQ Scripts for Track Wise and Argus using HP Quality Center.
Code Reviewed Java, PL-SQL and SQL components. 
Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
Managed and organized requirement coverage, Test Case Management and Defect Management using Quality Center. 
Conducted Installation Qualification and documented the test results, deviations and corrective actions.
Performed Functionality testing and Interface testing during the Operational Qualification.
Involved in developing Test Plans and Summary reports for the Track Wise system implementation.  
Performed production data analysis and suggested process parameters for process optimization, process control and product development.
Documented the Validation Summary Report (VSR) and created Traceability Matrix to keep track of all the requirements and test scripts.
Assist QA team to plan, perform UAT  update team, project manager about bug status, defects  project validation status.
Implemented the new raw materials for optimizing the costs incurred and process efficiency with the team lead-

MYLAN Inc., WV
Nov 2008 - Jan2010
Validation Consultant

Responsibilities :
Documented IQ, OQ, and PQ for different modules of Oracle Argus Safety, My Custom Reports and Oracle discoverer.
Developed Master Test Plan for LIMS implementation to define the test strategy and test cycles.
Performed Computer System Validation Assessment for Lab ware LIMS system to identify the validation deliverables for the project implementation.
Analyzed System Requirements to document in Function Requirements Specification (FRS) and Design Specifications (DS).
Assisted in the implementation of software systems in conformance with regulatory requirements as they pertain to 21 CFR Part 11, Part 211 and GAMP 4.0 standards along with validation of Information requirements management system. 
Performed GAP Analysis and also developed the corresponding Remediation plan.
Documented all materials during the testing phase of the project as well as tracked all deviations and corrective actions as part of test process.
Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre execution as well as post approval.
Developed Test Summary Report to summarize all test activities done in controlled test environment and documented the Test Scripts and analyzed them to check for compliance with 21 CFR part 11 rules of FDA
Managed system upgrades, enhancements, and maintenance in a FDA regulated environment.
Conducted Risk Analysis meetings to analyze the risk involved in implementing the Track Wise system in the existing business process.
Prepared Traceability Matrix to define the relationship between requirements, design specifications and test scripts.
Developed the Final Validation Summary Report and Go-Live memo to issue the LIMS system into production use.

InvaGen Pharmaceuticals, Inc.,  NY
Oct 2007 - Nov 2008
Validation-Compliance Analyst

Responsibilities :
Gathered User Requirements, Functional Requirements and generated Conformance Standard Documents.
Responsible for determining the System Risk Assessment (SRA) and Functional Risk Assessment   (FRA) for the equipments in accordance with cGLP and part 11 regulations.
Prepared Validation Master Plan (VMP) for validating analytical laboratory equipments and also Labware LIMS integration with ELN.
Conducted meetings with the system users to gather User Requirements.
Participated in updating the Requirement Traceability Matrix.
Developed and executed the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts for the new functionalities.
Involved in documenting and executing test plan, test cases and test scripts.
Participated as a team member to draft a Remediation Plan for Project Management approval after Gap Analysis.
Prepared Validation Summary Reports and Standard Operating Procedures.
Provided input and feedback to the QA team in the execution of the test plans and test cases.
Reviewed Change Control documentation for Instrument and equipment related work instructions for quality and compliance issues.
Trained users on the system operation and data entry into ELN.
Followed the Waterfall methodology of SDLC life cycle during the project.
Involved in preparation of Validation Deliverables (Validation Plan to Validation Summary Report) of involved systems software mainly TrackWise.
Interacted with the users, TrackWise developer team to qualify configured modules in TrackWise web team access and TrackWise administrator.
Created and maintained validation documentation for assigned products- projects.
Designed validation plans, oversee execution of the plans and report validation activities on validation summary reports.
Executed and Documented Validation Protocol documents like IQ, OQ, PQ and User Acceptance Testing. 
Managed compliance with 21 CFR Part 11 for assigned systems.
Monitored any deviation, addressed such to management team for Change Control.
Determined the need for revalidation based upon changes to systems.
Prepared and documented Validation Summary Reports.
Contributed to the overall development and maintenance of policies and procedures as related to compliance activities.

 Dr. Reddy*s laboratories,  IND.
 Jan 2006 -  Jul 2007.
Validation Engineer.

Responsibilities :
Coordinated with the project manager to write the Validation Master Plan.
Maintained and executed validation guidelines for testing the GMP, GCP, GLP sensitive transactions.
Developed IQ, OQ and PQ test scripts to test the application following strict GDP and 21CFR Part11.
Responsible for the overall coverage of requirements of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 Compliant.
Responsible for developing the Requirement Traceability Matrix (RTM) to track requirements during QA testing phase.
Performed Risk Assessments to verify whether the systems are Quality impacting and Part 11 compliant.
Analyzed and documented detailed program information working and interfacing with software developers and members of various other dependent departments.
Performed Manual Testing of the application prior to automate testing using Win Runner.
Responsible for allocation of test assignments to the team members. 


EDUCATION

BACHELORS IN ENGINEERING, JNTU, INDIA
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